A randomized controlled clinical trial to evaluate a combination of the antiviral remdesivir and the anti-inflammatory baricitinib for treatment of coronavirus disease 2019 (COVID-19) was announced Friday by theNational Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
According to an NIH press release, the trial is now enrolling hospitalized patients with COVID-19 in the US. It is expected to open at approximately 100 US and international hospitals and to enroll more than 1000 patients.
The clinical trial follows an announcement of preliminary results from the first iteration of NIAID's Adaptive COVID-19 Treatment Trial (ACTT), which evaluated remdesivir, the investigational broad-spectrum antiviral developed by Gilead Sciences. That analysis showed that patients with COVID-19 who received remdesivir had a statistically significant shorter time to recovery compared to patients who received placebo.
Remdesivir this week was granted emergency use authorization by the US Food and Drug Administration to treat patients critically ill with COVID-19.
In this next trial with baricitinib, called ACTT 2, all participants will receive remdesivir or remdesivir with baricitinib.
“We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19,” said NIAID Director Anthony S. Fauci, MD, in the NIH release. “ACTT 2 will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.”
Investigators will evaluate whether time to recovery is shorter in the combination arm relative to remdesivir alone.
Baricitinib (Olumiant, Eli Lilly and Co), approved for treatment of moderate-to-severe rheumatoid arthritis, inhibits cytokine signaling which plays a role in the severe lung inflammation seen in acute respiratory distress syndrome, experienced by some patients with COVID-19. The putative benefit of baricitinib for COVID-19 has been described in a case series of critically ill patients who recovered from COVID-19.
Remdesivir is administered as one 200-mg IV dose followed by a 100-mg once-daily IV dose for the duration of hospitalization up to a 10-day total course of treatment.
Baricitinib is administered as a 4-mg oral dose (or crushed and given through a nasogastric tube, if necessary) for the duration of hospitalization up to a 14-day total course of treatment.
Inclusion criteria for the trial are laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including a need for supplemental oxygen, abnormal chest X-rays, or illness requiring mechanical ventilation.
Recovery is defined as the participant being well enough for hospital discharge, ie, no longer requires supplemental oxygen or ongoing medical care in the hospital or is no longer hospitalized (with or without activity limits). Recovery is evaluated up until day 29.
A key secondary goal is to compare patient outcomes at day 15 on a scale ranging from fully recovered to death. Other secondary outcome variables will be compared, including mortality alone.
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